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A Prospective, Open Label, Controlled, Randomized, Multicenter Study to Assess the Efficacy and Safety of CLBS12 in Patients With Critical Limb Ischemia (CLI) Due to Arteriosclerosis Obliterans (ASO) With a Single-arm Substudy to Assess the Safety and Potential Efficacy of CLBS12 in Patients With CLI Due to Buerger's Disease (BD)

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Trial Profile

A Prospective, Open Label, Controlled, Randomized, Multicenter Study to Assess the Efficacy and Safety of CLBS12 in Patients With Critical Limb Ischemia (CLI) Due to Arteriosclerosis Obliterans (ASO) With a Single-arm Substudy to Assess the Safety and Potential Efficacy of CLBS12 in Patients With CLI Due to Buerger's Disease (BD)

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 10 Apr 2023

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At a glance

  • Drugs CLBS 12 (Primary)
  • Indications Chronic limb-threatening ischemia
  • Focus Therapeutic Use
  • Sponsors Caladrius Biosciences

    • Most Recent Events

    • 30 Mar 2023 According to a Caladrius Biosciences media release, data from the follow-up of all patients completed have been compiled and are being reviewed by the PMDA. The PMDA is expected to provide important perspective to be considered in preparation for the formal consultation meetings. If successful in the pre-consultation process, Lisata expects formal clinical consultation to occur during 2023.
    • 27 Jul 2022 Status changed from suspended to completed.
    • 05 May 2022 According to a Caladrius Biosciences media release, the outcome of the meeting with PDMA will provide important perspective to be considered in preparation for the formal consultation meetings which precede the Japanese new drug application.
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